TVC IMAGING SYSTEM, TVC INSIGHT CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

TVC IMAGING SYSTEM MODEL NIRS-MC7-70

FDA 510(k)

FDA Class 2 ·Cardiovascular

Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )

FDA 510(k)

FDA Class 2 ·Cardiovascular

LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70

FDA 510(k)

FDA Class 2 ·Cardiovascular

TVC Imaging System, TVC Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5

FDA 510(k)

FDA Class 2 ·Cardiovascular

TVC IMAGING SYSTEM, TVC INSIGHT CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

TVC IMAGING SYSTEM, TVC INSIGHT CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Catheter, Intravascular, Plaque Morphology Evaluation

FDA classification

FDA Class 2 ·Catheter, Intravascular, Plaque Morphology Evaluation

OXYGEN GENERATOR LIQUEFIER - (OGL)

FDA 510(k)

FDA Class 2 ·Anesthesiology

ORAGENE DX OGD-500.001

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DNA/RNA Shield SafeCollect Saliva Collection kit

FDA 510(k)

FDA Class 2 ·Microbiology

DNA/RNA Shield Collection Tube

FDA 510(k)

FDA Class 2 ·Microbiology

MIVI Mi-AXUS Guide Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

VersaD Delivery Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·4 OZ. STERILE UNPRESERVED SALINE SOLUTION

Suction Irrigation Tubing Set

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Bladeless Trocar; Bladed Trocar; Hasson Trocar

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology